BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE COVER PATCHES

    MDR report key: 5055857 · Received September 4, 2015

    Report

    Report Number
    0002242816-2015-00083
    Event Type
    Injury
    Date Received
    September 4, 2015
    Report Date
    August 6, 2015
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    PMA / PMN Number
    PP850022
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REPORT FOUR OF FIVE FOR THE SAME EVENT, SEE ALSO 2242816-2015-00080, 2242816-2015-00081, 2242816-2015-00082 AND 2242816-2015-00084.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE HAD A BURNING SENSATION WHERE THE PADS WERE PLACED. THE PATIENT REPORTED USING BOTH THE 72R ELECTRODES AND THE LT4500, AS WELL AS THE COVER PATCHES. THE PATIENT ADVISED THE BURNING SENSATIONS DID NOT START UNTIL SHE RECEIVED AND STARTED USING A NEW 20" LEAD WIRE. THE PATIENT REPORTS FOR THE PAST TWO WEEKS, THE PADS WERE LEAVING RAW SKIN. THE PATIENT REPORTED HER PRIMARY CARE PHYSICIAN PRESCRIBED AN OINTMENT AND ADVISED HER TO HOLD OFF ON USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587784 ELECTRODE COVER PATCHES ELECTRODE COVER PATCHES LOF EBI, LLC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other